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IL276229B2 - A multivalent pneumococcal protein-polysaccharide conjugate preparation - Google Patents
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IL276229B2 - A multivalent pneumococcal protein-polysaccharide conjugate preparation - Google Patents

A multivalent pneumococcal protein-polysaccharide conjugate preparation

Info

Publication number
IL276229B2
IL276229B2 IL276229A IL27622920A IL276229B2 IL 276229 B2 IL276229 B2 IL 276229B2 IL 276229 A IL276229 A IL 276229A IL 27622920 A IL27622920 A IL 27622920A IL 276229 B2 IL276229 B2 IL 276229B2
Authority
IL
Israel
Prior art keywords
mixed carrier
conjugate composition
multivalent pneumococcal
pneumococcal conjugate
vaccine
Prior art date
Application number
IL276229A
Other languages
Hebrew (he)
Other versions
IL276229A (en
IL276229B1 (en
Original Assignee
Sanofi Pasteur Inc
Sk Bioscience Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Pasteur Inc, Sk Bioscience Co Ltd filed Critical Sanofi Pasteur Inc
Publication of IL276229A publication Critical patent/IL276229A/en
Publication of IL276229B1 publication Critical patent/IL276229B1/en
Publication of IL276229B2 publication Critical patent/IL276229B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/315—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Streptococcus (G), e.g. Enterococci
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/34—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Corynebacterium (G)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Toxicology (AREA)
  • Virology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Claims (18)

1. / CLAIMS 1. A mixed carrier, multivalent pneumococcal conjugate composition, comprising different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, wherein the protein carrier is CRM197 or tetanus toxoid, and wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM197, wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5.
2. The mixed carrier, multivalent pneumococcal conjugate composition of claim 1, wherein the capsular polysaccharides from serotypes 1 and 5 are conjugated to the tetanus toxoid, and the capsular polysaccharides from serotypes 3, 4, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F are conjugated to CRM197.
3. The mixed carrier, multivalent pneumococcal conjugate composition of claim 1, wherein the capsular polysaccharides from serotypes 1 and 3 are conjugated to the tetanus toxoid, and the capsular polysaccharides from serotypes 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F are conjugated to CRM197.
4. The mixed carrier, multivalent pneumococcal conjugate composition of claim 1, wherein the capsular polysaccharides from serotypes 3 and 5 are conjugated to the tetanus toxoid, and the capsular polysaccharides from serotypes 1, 4, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F are conjugated to CRM197. 276229/
5. The mixed carrier, multivalent pneumococcal conjugate composition of any one of the preceding claims, further comprising an adjuvant.
6. The mixed carrier, multivalent pneumococcal conjugate composition of claim 5, wherein the adjuvant is an aluminum-based adjuvant.
7. The mixed carrier, multivalent pneumococcal conjugate composition of claim 6, wherein the adjuvant is selected from the group consisting of aluminum phosphate, aluminum sulfate, and aluminum hydroxide.
8. The mixed carrier, multivalent pneumococcal conjugate composition of claim 7, wherein the adjuvant is aluminum phosphate.
9. The mixed carrier, multivalent pneumococcal conjugate composition of any one of the preceding claims, wherein: the capsular polysaccharide from serotype 9N is conjugated to CRM197 in a state where the capsular polysaccharide from serotype 9N is activated to have a degree of oxidation of 2-19 or 5-and a molecular weight of 200-700 kDa; the conjugate formed between the capsular polysaccharide from serotype 9N and CRM 1has a molecular weight of 500-4,000 kDa; a ratio (W/W) of the capsular polysaccharide from serotype 9N to CRM197 in the conjugate formed between the capsular polysaccharide from serotype 9N and CRM197 is 0.5-2.5; and/or 15-60% of the conjugate formed between the capsular polysaccharide from serotype 9N and CRM197 has a Kd of 0.3 or below in a CL-4B column.
10. The mixed carrier, multivalent pneumococcal conjugate composition of any one of the preceding claims for use in prophylaxis against Streptococcus pneumoniae infection or disease in a subject. 276229/
11. A vaccine comprising the mixed carrier, multivalent pneumococcal conjugate composition of any one of claims 1-9 and a pharmaceutically acceptable excipient.
12. The mixed carrier, multivalent pneumococcal conjugate composition of any one of claims 1-9 or the vaccine of claim 11 for use in a method for prophylaxis of Streptococcus pneumoniae infection or disease in a subject, the method comprising administering a prophylactically effective amount of said mixed carrier, multivalent pneumococcal conjugate composition or said vaccine to the subject.
13. The mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of claim 12, wherein the subject is a human who is at least 50 years old and the disease is pneumonia or invasive pneumococcal disease (IPD).
14. The mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of claim 12, wherein the subject is a human who is at least 6 weeks old and the disease is pneumonia, invasive pneumococcal disease (IPD), or acute otitis media (AOM).
15. The mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of claim 14, wherein the subject is 6 weeks to 5 years of age, 2 to 15 months of age, or 6 to years of age.
16. The mixed carrier, multivalent pneumococcal conjugate composition for use of claim or the mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of any one of claims 12-15, wherein the subject is a human.
17. The mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of any one of claims 12-16, wherein the mixed carrier, multivalent pneumococcal conjugate composition or the vaccine is administered by intramuscular injection. 276229/
18. The mixed carrier, multivalent pneumococcal conjugate composition or the vaccine for use of any one of claims 12-17, wherein the mixed carrier, multivalent pneumococcal conjugate composition or the vaccine is administered as part of an immunization series. For the Applicants, REINHOLD COHN AND PARTNERS
IL276229A 2018-02-05 2019-02-04 A multivalent pneumococcal protein-polysaccharide conjugate preparation IL276229B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862626482P 2018-02-05 2018-02-05
KR20180045246 2018-04-18
PCT/US2019/016506 WO2019152921A1 (en) 2018-02-05 2019-02-04 Multivalent pneumococcal polysaccharide-protein conjugate composition

Publications (3)

Publication Number Publication Date
IL276229A IL276229A (en) 2020-09-30
IL276229B1 IL276229B1 (en) 2023-09-01
IL276229B2 true IL276229B2 (en) 2024-01-01

Family

ID=67478950

Family Applications (1)

Application Number Title Priority Date Filing Date
IL276229A IL276229B2 (en) 2018-02-05 2019-02-04 A multivalent pneumococcal protein-polysaccharide conjugate preparation

Country Status (14)

Country Link
US (2) US11147864B2 (en)
EP (1) EP3749358A4 (en)
JP (1) JP7288451B2 (en)
KR (1) KR102812816B1 (en)
CN (1) CN111757754B (en)
AU (1) AU2019215212B2 (en)
BR (1) BR112020014978A2 (en)
IL (1) IL276229B2 (en)
MX (1) MX2020007939A (en)
PH (1) PH12020551147A1 (en)
SA (1) SA520412580B1 (en)
SG (1) SG11202006387QA (en)
TW (1) TWI815860B (en)
WO (1) WO2019152921A1 (en)

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